ABL Bio is returning the antibody-drug conjugate (ADC) platform technology introduced from IntoCell, causing tension throughout the bio industry. Concerns have also been raised over potential damages to Samsung Bioepis and Y-Biologics, which entered into technology introduction contracts with IntoCell.
On the 9th, ABL Bio announced through a public disclosure that it would return the ADC platform 'Nexatecan' technology it introduced from IntoCell in October last year. This decision was made after a recent internal monitoring process revealed that a patent similar in structure to this platform technology was publicly disclosed in China. The company noted, "There was no issue during the patent analysis process at the time of contract, but we later discovered hidden patents, known as 'submarine patents,'" and added, "We requested immediate resolution from IntoCell, but due to a lack of appropriate action, we ultimately decided to return the technology."
◇ ABL Bio returns IntoCell technology amid 'submarine patent' controversy
'Submarine patents' refer to a system where a patent is not disclosed externally for 1 year and 6 months after application, allowing a third party to invest in or develop similar technology without knowing about the existence of the patent. After that period, the patent holder asserts infringement based on the registered patent.
An ABL Bio official said, "Given the situation where the patent for the Nexatecan technology has been disclosed in China, even if we develop new candidate substances with Nexatecan, we may not secure the patent or face the possibility of legal disputes due to infringement of rights held by third parties related to the patent."
IntoCell was founded in 2015 by CEO Park Tae-kyo, a co-founder of ADC specialist LigaChem Biosciences. It was listed on the KOSDAQ in May through a technology exception. ADC is a therapeutic technology that attaches drugs to antibodies for precise delivery to cancer cells. The three core technologies are the antibody, the payload (drug), and the linker (connection technology) that connects the two. IntoCell possesses three technologies: the linker platform 'Opas,' the payload platform 'PMT,' and the payload platform 'Nexatecan,' which is the subject of this return.
Nexatecan is a next-generation payload platform designed to reduce side effects caused by linker instability issues seen in existing ADC treatments, including AstraZeneca and Daiichi Sankyo's ADC anticancer drug 'Enhertu.' It is a technology that addresses the existing limitation of drugs falling off too quickly in the body and attacking normal cells, designed to release the drug only after reaching cancer cells. This platform can also be combined with IntoCell's linker platform, Opas. While Opas could only connect drugs with specific structures (phenols), Nexatecan can stably attach drugs with a wider variety of structures, expanding its applicability.
◇ Samsung Bioepis and Y-Biologics affected… 'Monitoring and response to submarine patents are more important'
So far, IntoCell has entered into a total of four technology transfer contracts: with Y-Biologics in 2017, Swiss ADC Therapeutics in December 2022, Samsung Bioepis in December 2023, and ABL Bio last year.
Y-Biologics clarified through its website the previous day that "the termination of the ADC platform contract with IntoCell is entirely unrelated to the substances jointly developed by Y-Biologics and IntoCell." The jointly developed anti-B7-H3 ADC candidate substance 'YBL-015' is a form that combines Y-Biologics' antibody with IntoCell's Opas linker technology and a variant of duocarmycin, indicating that it is an entirely separate technology from the problematic Nexatecan. YBL-015 has already completed patent registration in the United States, and registration examinations are underway in other countries.
Since a material transfer agreement (MTA) limited to the Opas linker platform has been entered into with ADC Therapeutics, it is expected that the issue of returning Nexatecan will have no impact.
The most concerned party appears to be Samsung Bioepis. IntoCell signed a joint research contract with Samsung Bioepis at the end of 2023, and is developing ADC candidate substances targeting up to five cancer types using all three platforms: Opas, PMT, and Nexatecan. It aims to enter preclinical trials within this year.
Concerns are being raised that this return issue could disrupt the joint research between the two companies. Particularly, the lack of clear performance reports over the past year and seven months following the signing of contracts has heightened worries.
Since the drug group included in Nexatecan amounts to 30 types, there is also an interpretation that if the problematic compound does not overlap, the likelihood of patent conflicts will be low. In fact, the compound used by ABL Bio was 'NxT3' from the Nexatecan series. If the candidate selected by Samsung Bioepis is different from NxT3, it could be unrelated to this situation.
In the bio industry, it is seen that IntoCell did not intentionally hide the problem but found it difficult to ascertain the existence of a third-party submarine patent registered in China. If ABL Bio confirmed the disclosure of this patent while it was still under examination, IntoCell could have mitigated the risk by preventing the registration. However, if registration had already been completed, there are interpretations suggesting that IntoCell would have had no means of action. IntoCell has not yet issued any statements.
Kim Seon-a, a researcher at Hana Securities, said, "We will need to see IntoCell's official position, but there are many similar cases during technology introduction. Even if it is not an intentional concealment, it poses a patent risk that could ultimately harm the technology introducers, making it crucial to maintain a rapid response system like ABL Bio for continuous monitoring of patent situations, requests for cancellation of third-party patent registrations, and technology returns."